Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05565365

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Transversalis fascia plane (TFP) block Procedure: Erector Spinae Plane (ESP) Block	N/A

Detailed Description

Inguinal hernia repair is one of the most common surgical procedures in the world. Annually, more than 20 million inguinal hernia repairs are conducted worldwide.

Uncontrolled postoperative pain increases the incidence of postoperative complications. Regional blocks, as a part of multimodal analgesia, can improve pain control in the postoperative period and reduce complications that may arise from using a single mode of analgesia. For example, reliance on opioid analgesia increases the incidence of pruritus, nausea, and vomiting, as well as respiratory depression.

Hebbard first described the ultrasound (US)-guided transversalis fascia plane (TFP) block in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves.

Erector spinae plane block (ESPB) is a type of facial plane block in which local anesthetic is administered in the plane located between the erector spinae muscle and thoracic transverse process. ESPB blocks the transmission of nociceptive stimuli through the dorsal/ventral rami of the spinal nerve roots, prevents afferent stimuli transmission, and inhibits efferent activation of the sympathetic nervous system and can thus provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery.The effect of ESPB is also achieved through the block of the lateral, posterior, and anterior thoracic wall resulting in multiple levels sensory blocks. Additional proposed mechanism of action could be explained by the epidural spread of the anesthetics.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Ultrasound-guided Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Post-operative Analgesia in Inguinal Hernia Repair Under General Anesthesia: a Randomized Controlled Study

Anticipated Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Transversalis fascia plane (TFP) block Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision	Procedure: Transversalis fascia plane (TFP) block Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision Other Names: TFP block
Active Comparator: Erector Spinae Plane (ESP) Block Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision	Procedure: Erector Spinae Plane (ESP) Block Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision Other Names: ESP Block

Arm

Intervention/Treatment

Placebo Comparator: Transversalis fascia plane (TFP) block

Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision

Procedure: Transversalis fascia plane (TFP) block

Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Other Names:

TFP block

Active Comparator: Erector Spinae Plane (ESP) Block

Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision

Procedure: Erector Spinae Plane (ESP) Block

Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Other Names:

ESP Block

Outcome Measures

Primary Outcome Measures

The intensity of postoperative pain [24 hours after surgery]
Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old

Exclusion Criteria:

Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
Altered cognitive function
Body mass index (BMI > 35 kg/m2)
Patients who have difficulty understanding the study protocol
Patients who have any known allergy to study medications
Advanced hepatic or renal failure
Chronic opioid consumption
Patient refusal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seham Mohamed Moeen Ibrahim, Assistant professor of Anesthesia and Intensive Care, Assiut University

ClinicalTrials.gov Identifier:

NCT05565365

Other Study ID Numbers:

SM 10 2022

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Hernia, Inguinal

Study Results

No Results Posted as of Oct 4, 2022